Acute hypercapnic respiratory failure is characterized by elevated arterial carbon dioxide levels and commonly occurs in patients with chronic respiratory diseases. Patients with type II respiratory failure who experience difficult weaning from invasive mechanical ventilation are at increased risk of post-extubation respiratory failure and reintubation. This randomized clinical trial compared high-flow nasal cannula (HFNC) with non-invasive ventilation (NIV) as respiratory support immediately after extubation in patients aged over 50 years with type II respiratory failure and difficult weaning. The primary objective was to compare reintubation rates at 72 hours and 7 days after extubation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
200
Heated and humidified high-flow oxygen was delivered through a nasal cannula immediately after extubation. The device provided adjustable high-flow oxygen to achieve the predefined oxygenation and respiratory-rate targets.
Positive-pressure ventilatory support was delivered immediately after extubation through a conventional oronasal mask using spontaneous/timed (S/T) ventilation, with pressure and inspired oxygen adjusted according to predefined respiratory and gas-exchange targets.
Benha University Hospital
Banhā, Qalyubia Governorate, Egypt
Reintubation Rate
Number and proportion of participants requiring reinstitution of invasive mechanical ventilation after planned extubation.
Time frame: At 72 hours and 7 days after extubation
Treatment Failure Rate
Treatment failure was defined as escalation from HFNC to NIV or invasive mechanical ventilation in the HFNC group and requirement for invasive mechanical ventilation in the NIV group.
Time frame: Within 48 hours after extubation
Ventilator-Free Days at Day 28
Number of days alive and free from invasive mechanical ventilation during the first 28 days after randomization.
Time frame: During the first 28 days after extubation
Duration of Post-Extubation Respiratory Support
Duration of respiratory support with HFNC or NIV following extubation.
Time frame: Through 72 hours after extubation
Arterial Blood pH
Arterial blood pH measured by arterial blood gas analysis after extubation.
Time frame: At 1, 12, 24, and 48 hours after extubation
Arterial Partial Pressure of Carbon Dioxide (PaCO2)
PaCO2 measured by arterial blood gas analysis after extubation.
Time frame: At 1, 12, 24, and 48 hours after extubation
Arterial Bicarbonate (HCO3)
Arterial bicarbonate concentration measured as part of arterial blood gas analysis after extubation.
Time frame: At 1, 12, 24, and 48 hours after extubation
PaO2/FiO2 Ratio
Ratio of arterial partial pressure of oxygen (PaO2) to fraction of inspired oxygen (FiO2), used to assess oxygenation after extubation.
Time frame: At 1, 12, 24, and 48 hours after extubation
Post-Extubation Complications
Incidence of post-extubation complications were recorded during follow-up in the HFNC and NIV groups.
Time frame: From extubation through 28 days after randomization
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